The process for NMPA certification (formerly known as CFDA) of medical devices in China typically involves several key steps and approval conditions:
Classification: Determine the classification of your medical device according to the Chinese Medical Device Classification Catalog (similar to the EU's classification rules). This classification will dictate the regulatory pathway and requirements.
Technical Documentation Preparation: Prepare a comprehensive technical file that includes all necessary documentation, such as device description, design drawings, clinical evaluation reports, biocompatibility testing, electrical safety and EMC testing reports, labeling, IFU, and evidence of a quality management system.
Testing and Evaluation: Conduct necessary testing and evaluations to demonstrate compliance with Chinese regulatory standards, including safety, performance, and quality requirements. This may involve testing in accredited laboratories.
Submission of Application: Submit your application for NMPA certification through the China NMPA Online Registration System (CIRS). Ensure all required documents and information are accurately filled out and submitted.
Technical Review: NMPA will conduct a technical review of your submission, evaluating the documentation and testing data to ensure compliance with applicable regulations and standards.
On-site Inspection (if applicable): Depending on the risk classification of the device, NMPA may conduct an on-site inspection of your manufacturing facilities and quality management system.
Review Committee: For certain high-risk devices, a review committee may be convened to evaluate the application and provide recommendations to NMPA.
Approval Decision: NMPA will issue a decision on your application based on the technical review, inspection findings (if applicable), and compliance with regulatory requirements.
Compliance with Chinese Standards: Medical devices must comply with applicable Chinese national standards, including safety, performance, and quality standards specified by NMPA.
Quality Management System: Evidence of a robust quality management system (QMS) that complies with ISO 13485 or an equivalent standard is typically required.
Clinical Data: Depending on the classification and risk level of the device, clinical data demonstrating safety and efficacy may be required. This can include clinical trials conducted in China or data from literature and studies.
Labeling and Instructions for Use: Ensure labeling and IFU are in compliance with Chinese regulatory requirements, including language (Chinese), content, and format.
Post-Market Surveillance: Commitment to post-market surveillance activities, including adverse event reporting and monitoring of device performance in the market.
Authorized Representative: For foreign manufacturers, appointing an Authorized Representative (AR) in China who takes responsibility for regulatory compliance and acts as a liaison with NMPA.
Navigating the NMPA certification process can be complex, especially for foreign manufacturers. Engaging with regulatory consultants or local representatives in China who are familiar with NMPA regulations and procedures can facilitate a smoother and more efficient certification process.
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